Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-02-22 @ 4:11 AM
Study NCT ID:
NCT00263861
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2005-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-10', 'studyFirstSubmitDate': '2005-12-07', 'studyFirstSubmitQcDate': '2005-12-07', 'lastUpdatePostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cutaneous sensation as measured by Semmes-Weinstein monofilaments', 'timeFrame': 'baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment'}, {'measure': 'Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument', 'timeFrame': 'baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment'}, {'measure': 'Vibration as measured by tuning fork', 'timeFrame': 'baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment'}, {'measure': 'Lower extremity muscle strength as measured by Dynamometer', 'timeFrame': 'baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment'}, {'measure': 'Blood pressure changes', 'timeFrame': 'baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment'}, {'measure': 'Glycemic control as measured by Glycosylated Hemoglobin Assay', 'timeFrame': 'baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neurotoxicity', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Neurotoxicity', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably.\n\nPURPOSE: This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine changes in peripheral nerve function in older patients with diabetes and metastatic solid tumors treated with taxane or platinum-containing chemotherapy regimens.\n* Determine the extent to which age, pre-existing diabetes mellitus, and level of glycemic control predict a differential pattern in outcome beyond the effect of the drugs in patients treated with these regimens.\n* Develop a clinical assessment that would predict whether or not patients with diabetes mellitus are more or less susceptible to the neurotoxic effects of chemotherapy.\n\nOUTLINE: This is a longitudinal study.\n\nPatients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control. Patients are evaluated at baseline, every 3 weeks during chemotherapy for up to 4 treatments, and at 2 months after completion of treatment.\n\nPROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of solid tumor\n\n * Metastatic disease (stage IV)\n* Planning neoadjuvant or adjuvant treatment of locoregional definitive or systemic therapy comprising ≥ 1 of the following:\n\n * Taxane (paclitaxel or docetaxel)\n * Platinum (cisplatin, carboplatin, or oxaliplatin)\n* Diagnosis of type I or II diabetes mellitus\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* No other disease that reduces peripheral nerve function (e.g., HIV/AIDS, uremia, spinal injuries, alcoholism, or CNS problems)\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* See Disease Characteristics\n* No prior chemotherapy\n* No prior or concurrent neurotoxic drugs (i.e., vincristine)'}, 'identificationModule': {'nctId': 'NCT00263861', 'briefTitle': 'Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study', 'orgStudyIdInfo': {'id': 'CWRU6Z03'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE-CWRU-6Z03', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'management of therapy complications', 'type': 'PROCEDURE', 'description': 'Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5047', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Constance Visovsky, PhD, RN, ACNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Constance Visovsky, PhD, RN, ACNP', 'oldOrganization': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}}}}